1. Field of the Invention
The present invention relates to an improved lancet unit having a safety sleeve that securely encloses and shields the contaminated sharp tip of a lancet. The safety sleeve is movable from an operative position which exposes the sterile lancet tip for use and into a fixed protective position which shields the lancet tip after use, and eliminates the risk of an accidental piercing of the user's fingers when the contaminated lancet is prepared for disposal.
2. Description of the Related Art
Lancets have long been employed to pierce or prick a patient's skin to provide a small outflow of blood that can be used in various medical tests. As described in expired U.S. Pat. No. 3,358,659 to Higgins, one type of lancet unit generally includes the lancet itself, usually an elongated metal rod with a sharp sterile tip, a plastic retainer member molded directly about the lancet and from which the sharp tip extends outwardly, and a removable cap connected to the plastic retainer member and in which the sterile tip is encased to prevent contamination prior to use.
Lancets are used both at home by the patient or in medical offices and hospitals by health care professionals, and can be used to prick the patient's skin either by manual penetration or in conjunction with a mechanical device into which the lancet unit is installed and then removed after use. In the home setting, most lancets are used by the patient with the mechanical device, which is designed to accept lancets of various sizes. In the medical office and hospital setting, lancets are often used manually in order to avoid the necessity of having to re-sterilize the mechanical device after each use. After the lancet unit has been used to prick the patient's skin, either manually or by means of the mechanical device, the sharp lancet tip is contaminated with the patient's blood. Because of the various high-risk, life-threatening diseases that are prevalent today throughout the world, used lancet units constitute an extremely hazardous form of waste. It is therefore essential that contaminated lancet tips be completely and securely shielded upon disposal of the used lancet units to prevent others, such as sanitation employees who routinely are unknowingly exposed to such types of hazardous waste, from being accidentally jabbed.
Thus, in the home use setting patients have been advised to discard used lancet units in a rigid container such as a coffee can or milk carton, but unfortunately many patients frequently fail to do this. In addition, although it is possible to dispose of a used lancet unit of the type described in the '659 patent by inserting the sharp contaminated tip back into the cap which was removed prior to use, this is generally not done. One reason for this is because the cap is fairly small and the hole in it is minuscule, so that the person attempting to recap the lancet unit is exposed to the risk of inadvertently jabbing himself with the contaminated lancet tip before it is finally inserted into the cap. Also, the cap can be lost or misplaced after being removed from the lancet unit prior to use, thereby precluding its replacement. Even if the lancet tip is replaced back into such a cap, however, there is a possibility that the cap can accidentally fall or be knocked off because the cap is not designed to be securely re-connected to the retaining member or the tip after the lancet has been used.
More recently, lancet units have been designed with protective caps that include a mouth, sized and adapted to fit securely over the end face of the lancet retainer member from which the tip extends, and a pocket into which the tip of a used lancet can be inserted and protectively enclosed. Although the enlarged mouth decreases the possibility that a person may accidentally jab himself when replacing this type of cap, the risk of such an occurrence still exists because the user's hand which grasps the cap is required to move in the direction of the sharp lancet tip in order to re-cap the lancet unit. Thus, if the user becomes momentarily distracted from the task, for example, the mouth of the cap may not be replaced precisely over the end face of the lancet retainer member and the user can still inadvertently jab himself with the contaminated lancet tip. In addition, a used lancet unit protected with such a cap might be mistaken for an unused unit.
The device of the present invention is designed to meet the need of providing a simple, easy to use protective cover that fixedly encloses and shields the sharp contaminated tip of a used lancet for disposal, while eliminating the risks that the user's hand will be accidentally jabbed when the cover is placed into its protective position or that a worker will be inadvertently jabbed during disposal of the lancet units.